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Pharmaceutical engineer skills for your resume and career
8 pharmaceutical engineer skills for your resume and career
1. PLC
- Reviewed and approved Equipment Qualifications Protocols and Final Reports which document PLC or Automated System software including SCADA.
- Ladder Logic reviews and PLC I/O address verification for automated equipment/systems.
2. Process Improvement
- Designed and oversaw process improvements and related projects including new and relocated equipment with and without plant shutdown.
- Lead Process Compliance group during process improvement initiatives and seek out new opportunities for efficiency and effectiveness.
3. FDA
The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.
- Completed approximately 25 additional Process Validations, several of which were successfully reviewed by the FDA during facility inspections.
- Stay ahead of regulatory trends by routinely reviewing FDA warning letters and participating in discussions with regulatory and validation interest groups.
4. API
- Conducted risk-based technology transfer of advanced intermediates and API to external Contract Manufacturing Organizations or internal scale-up facilities.
- Involved in architectural design and implementation/exposing dozens of REST and SOAP based identity API to end applications/developers.
5. Process Equipment
Process equipment refers to the machinery used in processing and refining industries. This equipment is responsible for a single job in the refinement process, which can vary from maintaining the flow of a chemical, controlling chemical reactions, or even storing chemicals. Process equipment can also be broken down into two categories, which are fixed and rotating equipment, depending on the movement required from the equipment.
- Generated, scheduled, and executed qualification of process equipment, facilities, utilities, and computerized systems.
- Authored, executed, and summarized manual cleaning development studies for new process equipment.
6. Sops
A standard operating procedure or simply SOP is a particular operation that needs to be done in accordance with the rules and guidelines of a company or an industry. It is an important way for a company to run smoothly, especially in small businesses. It is like a practice wherein everything an individual or an employee is under a particular standard that is implemented.
- Authored quality and production SOPs and ensured compliance with cGMP, ICH, and EU regulations.
- Supported SOPs, Operational Handbook, and Controls Strategy documentation development.
7. Process Validation
Process validation refers to the accumulation and analysis of data, starting from the process design stage to production, which provides scientific evidence that the process can routinely deliver quality products. To develop an effective process validation strategy, you need to ensure that each of its three stages has been properly taken care of. The first stage is process design, where the processes are defined. The second stage is process qualification, where the process, which has been designed earlier, is evaluated to make sure it can reproduce reliable and consistent levels of quality. The final stage is continued process verification that involves ongoing validation to ensure the process is under control.
- Coordinated and executed equipment IQ/OQ/PQ and process validations as required for the facilities.
- Identified any potential gaps and areas for improvement after analysis of all documentation gathered during the process validation activities.
8. Cleaning Validation
- Authored facility Cleaning Validation Master Plans.
- Executed cleaning validation and verification protocols
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List of pharmaceutical engineer skills to add to your resume
The most important skills for a pharmaceutical engineer resume and required skills for a pharmaceutical engineer to have include:
- PLC
- Process Improvement
- FDA
- API
- Process Equipment
- Sops
- Process Validation
- Cleaning Validation
Updated January 8, 2025